Status:
NOT_YET_RECRUITING
A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Uterine Cervical Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages. The standard treatment for these stages is concurrent chemoradiotherapy, but this...
Detailed Description
Descriptive summary Objectives Primary objective • To assess the effectiveness of adjuvant sodium-copper-chlorophyllin in reducing the cumulative incidence of late grade 2 or higher RT-related gast...
Eligibility Criteria
Inclusion
- Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix
- Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.
- Subjects who exceed the dose constraints of:
- Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
- Bladder D 2cm³ EQD2 ³ more than 80 Gy
- Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:
- Haemoglobin: ≥ 8 g/dl
- ANC ≥ 1,500/mm\^3
- Platelet count 100,000/mm\^3
- Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)
- Bilirubin: ≤ 2 x Upper limit of normal (ULN)
- AST and ALT: ≤ 1.5 x ULN
- Subjects willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
- Ability to understand and willingness to sign an informed consent document
Exclusion
- Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation
- Subjects with clinically significant decreased hematologic reserves, with major organ failure, severe electrolyte or metabolic abnormalities, any active infection or any other medical condition that may interfere with the ability to receive study treatment
- HIV positive patients
- Subjects with a history of blood dyscrasias
- Subjects consuming any other concurrent investigational agents
- Subjects with any other previous or current malignancy or RT that is likely to interfere with the protocol treatment, or any other condition which, according to the principal investigator, might make an individual unsuitable for this study
- Subjects participating in any other clinical study within 90 days before enrolment in the study
- Subjects on active anti-coagulant treatment
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT07164534
Start Date
September 1 2025
End Date
September 1 2030
Last Update
September 10 2025
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